Clinical Trials /

Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia

NCT00412594

Description:

This phase II trial studies the side effects and how well cladribine and rituximab work in treating patients with hairy cell leukemia. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cladribine together with rituximab may kill more cancer cells.

Related Conditions:
  • Hairy Cell Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia
  • Official Title: Phase II Study of 2-Chlorodeoxyadenosine (2CDA) Followed by Rituximab in Hairy Cell Leukemia

Clinical Trial IDs

  • ORG STUDY ID: 2004-0223
  • SECONDARY ID: NCI-2012-01394
  • SECONDARY ID: 2004-0223
  • SECONDARY ID: P30CA016672
  • NCT ID: NCT00412594

Conditions

  • Hairy Cell Leukemia
  • Recurrent Hairy Cell Leukemia

Interventions

DrugSynonymsArms
Cladribine2-CdA, 2CDA, CdA, Cladribina, Leustat, Leustatin, Leustatine, RWJ-26251Treatment (cladribine and rituximab)
RituximabABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Rituxan, Rituximab ABBS, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar IBI301, Rituximab Biosimilar JHL1101, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, rituximab biosimilar TQB2303, rituximab-abbs, RTXM83, TruximaTreatment (cladribine and rituximab)

Purpose

This phase II trial studies the side effects and how well cladribine and rituximab work in treating patients with hairy cell leukemia. Drugs used in chemotherapy, such as cladribine, work in different ways to stop the growth of cancer cells either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cladribine together with rituximab may kill more cancer cells.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To demonstrate the efficacy in achieving complete response of combination of cladribine
      administered intravenously over 2 hours for 5 days followed by rituximab weekly for 8 weeks
      in patients with untreated or previously treated hairy cell leukemia.

      II. To examine the efficacy of rituximab to eradicate minimal residual disease (MRD) after
      cladribine therapy (as assessed by immunophenotyping of bone marrow and peripheral blood).

      III. To examine the effect of addition of rituximab to cladribine on the long term
      disease-free (DFS) and overall survival (OS) (as compared with historical controls).

      IV. To evaluate potential predictors of outcome including molecular and flow evaluations of
      MRD, as well as other potential molecular predictors such as v-raf murine sarcoma viral
      oncogene homolog B1 (BRAF).

      OUTLINE:

      Patients receive cladribine intravenously (IV) over 2 hours once daily (QD) on days 1-5 and
      rituximab IV once weekly for 8 weeks beginning on day 28 in the absence of disease
      progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 3 months for 1 year.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (cladribine and rituximab)ExperimentalPatients receive cladribine IV over 2 hours QD on days 1-5 and rituximab IV once weekly for 8 weeks beginning on day 28 in the absence of disease progression or unacceptable toxicity.
  • Cladribine
  • Rituximab

Eligibility Criteria

        Inclusion Criteria:

          -  Age 18 years and older

          -  Diagnosis of hairy cell leukemia (HCL) established by bone marrow examination

          -  Patients with relapsed disease are eligible if they have had no more than one prior
             therapy

          -  Women of child-bearing potential must use birth control (oral contraceptive, barrier,
             abstinence or any other acceptable method) for the duration of the study

          -  Performance status =< 3

          -  Creatinine less than or equal to 2.0 unless related to the disease

          -  Bilirubin less than or equal to 3.0

          -  Transaminases less than or equal 3 x upper limit of normal unless related to the
             disease

          -  No prior investigational agent in the 4 weeks prior to initiation of therapy

        Exclusion Criteria:

          -  Unable or unwilling to sign the consent form

          -  Known infection with human immunodeficiency virus (HIV), hepatitis B or C

          -  Presence of active infection

          -  Presence of central nervous system (CNS) metastases

          -  New York Heart Association classification III or IV heart disease

          -  Prior chemotherapy (last 4 weeks)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Efficacy of rituximab on achievement of complete response after therapy with cladribine
Time Frame:At 12 weeks
Safety Issue:
Description:Defined as the absence of hairy cells in the bone marrow or the presence of less than 1 percent atypical cells and the disappearance of all evidence of hairy cell leukemia on physical examination. Monitored using the method of Thall, Simon, Estey as extended by Thall and Sung.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:M.D. Anderson Cancer Center

Last Updated

March 23, 2020